A MEDICINAL FORMULATION FOR TREATMENT OF COUGH, SORE THROAT AND THROAT INFECTION.

FIELD OF INVENTION

The present invention relates to providing a medicinal/nutraceutical formulation essentially comprising of Anacyclus pyrethrum, Zinc and Menthol in a definite proportion for treatment of cough, sore throat and related symptoms like throat infection.

BACKGROUND AND PRIOR ART

Sore throatand cough do not have permanent cure, to deal with them exists various products, formulations and mixtures as medicaments for the treatment of cough.

Sore throat and cough normally occurs for various reasons commonly known for weather, dust, smoke and due to certain allergic pre-conditions.

Sore throat and cough also occurs due to non-immunity of a human body to certain types of food habits like very cold food particularly ice-creams and dairy products.

There are various kinds of formulations available for treatment of cough normally Antitussives, Cough suppressants or Antihistamines. However, these formulations and medicaments try to treat only cough.

There has been always a need felt to provide for a medicament that can successfully soothe irritated oral and nasal tissues as well as cure problems of throat infection and sore throat which are associated with cough.

The present invention is an attempt to provide for a formulation that essentially comprises of Anacyclus pyrethrum, Zinc and Menthol in a definite proportion to give a complete solution to cough, sore throat as well as throat infection. OBJECT OF THE INVENTION

It is the object of present invention to provide for the first time a combination of three substances in one molecule that is Anacyclus pyrethrum, Zinc and Menthol.

It is yet another object of the invention to provide a formulation which helps in treatment of cough and sore throat in shorter duration.

It is yet further object of the invention to provide for a formulation that stops multiplication of viruses and thereby controls infection of throat during the cough symptoms.

It is yet further object of the invention to provide for a formulation which can prevent redness in throat, hoarseness, altered voice quality, swelling and dry mouth conditions during cough and sore throat.

It is yet further object of the invention to provide for a medicinal/nutraceutical formulation which is without the intervention of chemical substance and hence, conveniently consumable by people with allergic problems and symptoms.

DETAIL DESCRIPTIONS

The present invention is a process to prepare a product in the form of medicinal and nutraceutical formulation having synergistic effect of three key ingredients in definite proportion that is Anacyclus pyrethrum, Zinc and Menthol.

In the above formulation, zinc helps in effectively fight against a severe cough and sore throat conditions in a very short duration, zinc further also helps in controlling the spreading and multiplying of viruses and thereby preventing a situation of infection in throat as well as in nasal area of the mouth.

Anacyclus pyrethrum has an effective utility to prevent sore throat, throat infection, dry mouth condition, swelling and redness in throatduring cough situation.

Menthol is effective against cough Clinical trial protocol summary

Single-blind, Randomized, clinical Study of THROZEN (Cough Drop Formulation) was done on 108 subjects with existing cough and sore throat condition. The Subjects were given the cough drop after they were enrolled in the study and were followed up for a period of 7 to 14 days. The Cough and Sore throat severity, Dry mouth, Itching of throat, Voice quality, Redness of throat and Hoarseness were recorded on the 7th day and on the 14th day of treatment during follow-up visits.

Efficacy of Throzen

Primary Efficacy Variable:

Demographics, Medical History, Assessment of vitals, Clinical examination - Haematology (Haemoglobin (Gm%), Total WBCs count, Differential count, Polymorphs, Lymphocyte, Eosinophils, Monocyte) and Concomitants Medication treatment.

Secondary Efficacy Variable (Follow-up visits on day 07 and day 14):

1 ) Cough

2) Sore throat

3) Dry mouth

4) Itching of throat

5) Voice quality

6) Redness of throat

7) Hoarseness

Subject’s outcome:

The Clinical trial of Throzen Cough drops was completed successfully. In this study, total numbers of patients screened were 230 and 108 number of subjects were enrolled for the study.

Subjects showed positive response during the treatment period and the effects of cough drops are found satisfactory. 08 subjects with mild/moderate secondary variable parameters showed results within 07 days treatment and discontinued the study.

All the subjects studied showed a significant decrease in the frequency and severity of the cough and sore throat.

Throzen associated Safety

No any adverse effects were observed for any subjects. All the subjects studied showed a significant decrease (p<0.0001 ) in the frequency and severity of the cough and sore throat. Assessment was based on improvement in symptoms, acceptability and overall efficiency and safety as reported by the physician and the subjects.

Synergy

^*** Multiple (Cough, Sore throat, Dry mouth, Itching of throat, Voice quality,

Redness of throat and Hoarseness) symptoms were cured due to synergistic effect of 3 key ingredients present in Throzen

^*** None of the 3 individual key ingredients of Throzen can cure all these 7 symptoms alone

^*** As proven in table 1 , both Anacyclus pyrethrum and zinc are effective against sore throat. The efficacy of zinc [Ref. 2] is only 18% when used as a sole ingredient. However the efficacy of Throzen against sore throat is high (98.67%) due to synergistic effect of Anacyclus pyrethrum and zinc together.

^*** As proven in Table 1 , Zinc is effective against symptom“Itching of throat”.

However Anacyclus pyrethrum is effective against dry mouth and redness associatewith the throat infection. This characteristic of Anacyclus pyrethrum sequentially reduces the itching associated with throat infection as the dry mouth and redness is cured by Anacyclus pyrethrum gradually. Hence the efficacy of zinc against itching of throat [Ref. 2] which was only 33% individually has risen to 99.06% due to synergistic combination of Anacyclus pyrethrum and zinc together as proven in Table 2. ^*** Symptoms like cough and hoarseness which were reported to be treated only 46% and 43% respectively with zinc solely [Ref. 2], were treated enhancely to 98.8% and 98% respectively due to Anacyclus pyrethrum, zinc and menthol synergistic combination as proven in Table 2.

^*** Throzen formulation significantly treated symptoms of dry mouth, altered voice quality and redness in throat to 98.34%, 97.58% and 97.66% respectively as proven in Table 2.

Surprisingly it is found that after the clinical trial of Throzen formulation on total numbers of 108 subjects that the formulation has no adverse effect and has clinically proven efficacy and safety, this can be evidenced from the Table -A, which shows the score details of secondary efficacy variable.

Also the above clinical studies showed result of various statistics of secondary efficacy with Mean Value, SEM and value of paired T-test, this is shown in Table -B

The Throzen formulation was identified to be having superior secondary efficacy which can be evidence from the charts of secondary variable parameter codes in Chart -I for cough, Chart - II for sore throat, Chart -III for dry mouth, Chart -IV for Itching of throat, Chart -V for voice quality Chart -VI for redness of throat, Chart -VII for Hoarseness.

In particular based on data provided the subject matter invented medicinal/nutraceutical formulation is safe and highly efficient for treatment of cough, sore throat and throat infection without adverse effects and associated allergic problems in comparison to other formulations which are made up of chemical compounds Table A

Table B

Chart I

Chart II

Chart III

Chart IV

Chart V

Chart VI ίί _÷

Chart VII